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CompletedNCT00738673Updated Jan 18, 2013Results posted

Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

A Phase 2 interventional study of degarelix in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Completed at 15 sites in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-18.

Sponsored by Ferring Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

This was an open-label, multi-centre, uncontrolled, exploratory trial with a duration of 12 months in two cohorts. The trial aimed to investigate Degarelix as a second-line hormonal treatment in Prostate Cancer patients who experienced PSA-Failure following gonadotropin-releasing hormone (GnRH) agonist treatment. The two cohorts differ in Testosterone levels at inclusion.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Hormone refractory prostate cancer
  • Agonist treatment failure
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 37 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patient has given written informed consent before any trial-related activity is performed.
  • Patient is 18 years or older.
  • Histologically confirmed prostate cancer.
  • Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
  • Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
  • Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Estimated life expectancy at least 12 months.

Exclusion criteria

Exclusion Criteria:

  • Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
  • Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
  • Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
  • Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
  • Known hypersensitivity towards any component of the investigational medical product.
  • History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Known or suspected clinically significant liver and/or biliary disease.
  • Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
  • Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
  • Previous participation in any degarelix trial.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Degarelix

    Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

    Drug: degarelix

Interventions

  • Drugdegarelix

    Starting dose of 240 mg (40 mg/mL). Maintenance doses of 80 mg (20 mg/mL).

    Also known as: FE200486

06

What researchers measure

Primary outcomes

  1. Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline

    Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level

    Time frame: Day 0 (baseline), 3 months

Secondary outcomes

  1. Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline

    Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level. Per protocol, the one month timeframe was only analyzed for cohort 2.

    Time frame: Day 0 (baseline), 1 month

  2. Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline

    Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level. Per protocol, the two month timeframe was only analyzed for cohort 2.

    Time frame: Day 0 (baseline), 2 months

  3. Participants at Testosterone Castrate Level Throughout the Study

    Participants who had no post-baseline serum testosterone level above castrate level which was \<=0.5 ng/mL.

    Time frame: up to month 12

  4. Change From Baseline in Serum Levels of Testosterone at the Last Visit

    Time frame: Day 0 (baseline), up to month 12 (last visit)

  5. Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit

    Time frame: Day 0 (baseline), up to month 12 (last visit)

  6. Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit

    LH is measured in IU/L

    Time frame: Day 0 (baseline), up to month 12 (last visit)

  7. Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit

    Time frame: Day 0 (baseline), up to month 12 (last visit)

  8. Participants at Testosterone Level <=0.2 ng/mL Throughout the Study

    Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.

    Time frame: up to month 12

  9. Participants at Testosterone Level <=0.32 ng/mL Throughout the Study

    Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL

    Time frame: up to month 12

  10. Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study

    Counts of participants who had PSA progression during the study. PSA progression was defined as PSA \>+10% of baseline value.

    Time frame: up to month 12

  11. Kaplan-Meier Estimate for Overall Survival

    The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

    Time frame: up to month 12

07

Results

Posted Jan 18, 2013

Participant flow

Cohort 1 comprised a broad spectrum of biochemically relapsed participants (on castrate level) on long term hormonal treatment in different stages of the disease (primarily advance stages), however not in need of chemotherapy. The second cohort was similar, although testosterone levels were to be above castrate level (≥0.32 ng/mL).

Participant flow — Overall Study
MilestoneDegarelix - Cohort 1Degarelix - Cohort 2
Started2512
Intent to treat population2412
Completed11
Not completed2411
Withdrew: Adverse event10
Withdrew: Lack of efficacy198
Withdrew: Protocol violation12
Withdrew: Withdrawal by subject31

Outcome measures

PrimaryParticipants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline

Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level

Time frame:
Day 0 (baseline), 3 months
Reported as:
Number · percentage of participants
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
percentage of participantsDegarelix - Cohort 1Degarelix - Cohort 2
Response16.67 (4.74 to 37.38)33.33 (9.92 to 65.11)
No Response83.33 (62.62 to 95.26)66.67 (34.89 to 90.08)
SecondaryParticipants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline

Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level. Per protocol, the one month timeframe was only analyzed for cohort 2.

Time frame:
Day 0 (baseline), 1 month
Reported as:
Number · percentage of participants
Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
percentage of participantsDegarelix - Cohort 1Degarelix - Cohort 2
Response—66.67 (29.93 to 92.51)
No Response—33.33 (7.49 to 70.07)
SecondaryParticipants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline

Response to treatment was defined as: * Response (stabilisation or decrease): Difference ≤ +10% of Baseline level * No response (increase): Difference \> +10% of Baseline level. Per protocol, the two month timeframe was only analyzed for cohort 2.

Time frame:
Day 0 (baseline), 2 months
Reported as:
Number · percentage of participants
Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
percentage of participantsDegarelix - Cohort 1Degarelix - Cohort 2
Response—40.00 (12.16 to 73.76)
No Response—60.00 (26.24 to 87.84)
SecondaryParticipants at Testosterone Castrate Level Throughout the Study

Participants who had no post-baseline serum testosterone level above castrate level which was \<=0.5 ng/mL.

Time frame:
up to month 12
Reported as:
Number · participants
Participants at Testosterone Castrate Level Throughout the Study
participantsDegarelix - Cohort 1Degarelix - Cohort 2
Participants at Testosterone Castrate Level Throughout the Study2411
SecondaryChange From Baseline in Serum Levels of Testosterone at the Last Visit
Time frame:
Day 0 (baseline), up to month 12 (last visit)
Reported as:
Mean · ng/mL
Change From Baseline in Serum Levels of Testosterone at the Last Visit
ng/mLDegarelix - Cohort 1Degarelix - Cohort 2
Change From Baseline in Serum Levels of Testosterone at the Last Visit-0.039 ± 0.175-0.038 ± 0.631
SecondaryChange From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
Time frame:
Day 0 (baseline), up to month 12 (last visit)
Reported as:
Mean · ng/mL
Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
ng/mLDegarelix - Cohort 1Degarelix - Cohort 2
Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit18 ± 2954 ± 116
SecondaryPercent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit

LH is measured in IU/L

Time frame:
Day 0 (baseline), up to month 12 (last visit)
Reported as:
Mean · percentage of baseline
Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit
percentage of baselineDegarelix - Cohort 1Degarelix - Cohort 2
Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit58 ± 286123 ± 277
SecondaryChange From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
Time frame:
Day 0 (baseline), up to month 12 (last visit)
Reported as:
Mean · IU/L
Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
IU/LDegarelix - Cohort 1Degarelix - Cohort 2
Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit-1.64 ± 3.01-2.01 ± 1.72
SecondaryParticipants at Testosterone Level <=0.2 ng/mL Throughout the Study

Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.

Time frame:
up to month 12
Reported as:
Number · participants
Participants at Testosterone Level <=0.2 ng/mL Throughout the Study
participantsDegarelix - Cohort 1Degarelix - Cohort 2
Participants at Testosterone Level <=0.2 ng/mL Throughout the Study—8
SecondaryParticipants at Testosterone Level <=0.32 ng/mL Throughout the Study

Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL

Time frame:
up to month 12
Reported as:
Number · participants
Participants at Testosterone Level <=0.32 ng/mL Throughout the Study
participantsDegarelix - Cohort 1Degarelix - Cohort 2
Participants at Testosterone Level <=0.32 ng/mL Throughout the Study—9
SecondaryParticipants With Prostate-Specific Antigen (PSA) Progression Throughout the Study

Counts of participants who had PSA progression during the study. PSA progression was defined as PSA \>+10% of baseline value.

Time frame:
up to month 12
Reported as:
Number · participants
Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study
participantsDegarelix - Cohort 1Degarelix - Cohort 2
Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study2111
SecondaryKaplan-Meier Estimate for Overall Survival

The overall survival time was defined as number of days from first treatment dose to date of death. If a patient did not die then the patient's data were censored at the date of last visit.

Time frame:
up to month 12

No measurements were reported for this outcome.

Adverse events

Collected over up to month 13. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Degarelix - Cohort 1—3/25 (12%)18/25 (72%)
Degarelix - Cohort 2—1/12 (8.3%)10/12 (83.3%)
Most frequent serious events
Most frequent serious events
EventDegarelix - Cohort 1Degarelix - Cohort 2
Anaemia of malignant diseaseBlood and lymphatic system disorders0/251/12
AnaemiaBlood and lymphatic system disorders0/251/12
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/250/12
Carotid artery stenosisNervous system disorders1/250/12
Bladder tamponadeRenal and urinary disorders1/250/12
Most frequent other events
Showing 10 of 21
Most frequent other events
EventDegarelix - Cohort 1Degarelix - Cohort 2
Injection site erythemaGeneral disorders10/256/12
Injection site swellingGeneral disorders8/255/12
Injection site painGeneral disorders3/250/12
ConstipationGastrointestinal disorders0/251/12
Stomach discomfortGastrointestinal disorders0/251/12
VomitingGastrointestinal disorders0/251/12
General physical health deteriorationGeneral disorders0/251/12
PyrexiaGeneral disorders0/251/12
Urinary tract infectionInfections and infestations1/251/12
BronchitisInfections and infestations0/251/12

Baseline characteristics

Age Continuous
Age Continuous(years)Degarelix - Cohort 1Degarelix - Cohort 2Total
Mean72.7 ± 9.1176.5 ± 4.6873.9 ± 8.08
Sex: Female, Male
Sex: Female, Male(Participants)Degarelix - Cohort 1Degarelix - Cohort 2Total
Female000
Male241236
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Degarelix - Cohort 1Degarelix - Cohort 2Total
Not Hispanic or Latino241236
HIspanic or Latino000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Degarelix - Cohort 1Degarelix - Cohort 2Total
White241236
Other000
Weight
Weight(kg)Degarelix - Cohort 1Degarelix - Cohort 2Total
Mean90.5 ± 17.387.6 ± 11.089.6 ± 15.5
Height
Height(meters)Degarelix - Cohort 1Degarelix - Cohort 2Total
Mean1.74 ± 0.061.72 ± 0.051.73 ± 0.06
Stage of Prostate Cancer at Diagnosis
Stage of Prostate Cancer at Diagnosis(participants)Degarelix - Cohort 1Degarelix - Cohort 2Total
Localized448
Locally advanced11112
Metastatic628
Not classifiable358
Stage of Prostate Cancer at Enrolment
Stage of Prostate Cancer at Enrolment(participants)Degarelix - Cohort 1Degarelix - Cohort 2Total
Localized123
Locally advanced909
Metastatic7512
Not classifiable7512

2 further baseline measures are reported on the registry.

08

Study locations

15 sites
  • Urologische Praxis
    Bautzen, Germany
  • Urologische Klinik
    Berlin, Germany
  • Urologische Praxis
    Berlin, Germany
  • Urologische Praxis
    Borken, Germany
  • Urologische Praxis
    Erkrath - Hochdal, Germany
  • Urologische Praxis
    Hagenow, 19230, Germany
  • Martini Klinik
    Hamburg, Germany
  • Urologische Praxis
    Husum, Germany
  • Urologische Praxis
    Kirchheim, Germany
  • Urologische Praxis
    Köln, Germany
  • Urologische Praxis
    Lauenburg/Elbe, Germany
  • Urologische Praxis
    Leipzig, Germany
  • Urologische Praxis
    Markkleeberg, Germany
  • Urologische Klinik
    Planegg, Germany
  • Wissenschaftskontor Nord
    Rostock, Germany
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00738673
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 20, 2008
Start date
Jul 2008
Primary completion
Dec 2011
Completion
Dec 2011
Results posted
Jan 18, 2013
Last update
Jan 18, 2013

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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